FDA has edged closer and closer to regulating IVDs developed in laboratories rather than by a typical manufacturer registered with the FDA. Public debate pits an initiative for imposing standardized regulatory controls against decades of using laboratory-developed tests by licensed clinicians. This brings to mind some very practical questions? How do physicians change the logistics of their practice? How can clinical institutions provide specialized care when their tools are taken away? FDA regulation hammers specialized medical practices by throwing the process into a regulatory mill. A test developed by the doctor would now require production by manufacturer, who is subject to layers and layers of regulatory controls. As a consequence, there is no useful or timely turn around for supplying special in vitro reagents. Can the doctor order, receive and use a special reagent the same day now?
The webinar clarifies the regulatory concern that FDA has and whether subjecting Laboratory Developed Tests (LDTs) to FDA’s device Quality System Regulation can make a measurable difference in the safety and effectiveness (reliability) of special IVDs. The arguments on both sides of the issue will be identified and how regulation may adversely impact the quality of health care we have today. The presumption by FDA is that regulation will improve these special IVDs and, thereby, improve the quality of health care.
You will learn how reporting regulations, such as FDA’s manufacturing regulations (Quality System Regulation (21 CFR Part 820)), Medical Device Reporting (21 CFR Part 803) and Reports of Corrections and Removals (21 CFR Part 806) would apply to LDTs. Once you identified the regulatory obligations, the logistical issues will be discussed and the types of game plans that may be necessary.
Areas to be Covered:
Reasons for FDA regulation
Use and availability of LDTs
Identify logistical risks
Steps for implementation
Interactive Q&A Session
Who will Benefit:
Pathology practice groups
Medical institutions (hospitals) using Laboratory Developed Tests
Healthcare maintenance organizations
Medical device and diagnostic manufactures
Risk managers for healthcare practices
Regulatory affairs managers for IVD manufacturers
Cost control consultants for healthcare practices